Clinical risk factors for pancreatic cancer: protocol for an umbrella review

Introduction
Identifying cancer earlier can help save lives. An increasingly popular approach to diagnosing cancer earlier is in the development of risk prediction models to be applied to the electronic healthcare record of patients. Development of these models requires systematic and thorough identification of the risk factors that might increase an individual’s propensity to develop the disease. This protocol sets out the methods for an umbrella review to identify risk factors that might be included in these models. The example used is pancreatic cancer, a disease with a high percentage of late-stage diagnoses and consequent high mortality.

Methods and analysis
Relevant systematic reviews will be identified through searching of MEDLINE and EMBASE via Ovid and the Science Citation Index Expanded of the Web of Science Core Collection. Screening will be performed by two independent reviewers using Covidence software and the results reported as a Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow diagram. Data from eligible studies will be extracted independently by two reviewers and each systematic review will be graded using defined credibility assessment criteria and the ROBIS (Risk of Bias in Systematic Reviews) tool. Results will be presented in detail for each paper. Summary results for each risk factor will be discussed in the narrative and summarised using a table, graphical summary and an infographic.

Ethics and dissemination
Ethical approval is not required for this review. Results of the review will be disseminated by publication in a peer-reviewed journal and presented at conferences.

PROSPERO registration number
CRD42024526338.

Read More

Assessment of muscle strength in elderly as a screening method for sarcopenia in primary care: a scoping review

Objectives
To identify and map the available evidence for whether a test of handgrip strength (HGS) and/or the chair stand test (CST) have been used as screening tools for the detection of sarcopenia in elderly individuals within primary care settings.

Design
This study was designed as a scoping review, in accordance with the methodological framework for scoping reviews, developed by Arksey and O’Malley, and using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for scoping reviews.

Data sources
A literature search was conducted to identify relevant articles listed in PubMed and Scopus databases up to 16 October 2023.

Eligibility criteria
Studies including individuals aged ≥60 years who had undergone assessments of HGS and/or the CST in primary care settings were included.

Data extraction and synthesis
Following the article selection process, based on predetermined criteria for inclusion and exclusion, the selected articles were analysed regarding population demographics, the setting in which the research was conducted, the study design, used diagnostic tools and reported results.

Results
The search yielded 282 unique articles, of which 7 were included in the final analysis. All seven included articles had a cross-sectional study design, whereof one also had a longitudinal 3-year follow-up. The number of participants ranged from 75 to 719. Three of the articles used the diagnostic criteria presented by European Working Group on Sarcopenia in Older People (EWGSOP), two used the criteria by Asian Working Group for Sarcopenia 2019, one used the EWGSOP2 criteria and one applied both the EWGSOP and EWGSOP2 criteria to their data. All the articles used HGS to assess muscle strength. CST was not used for this purpose in any of the articles, although it was used to estimate physical performance or as part of the short physical performance battery. The prevalence of sarcopenia in the included articles was 12.0%–20.7%, while the prevalence of possible sarcopenia was 69.9%–73.3% and that of probable sarcopenia was 25.5%–94%.

Conclusion
None of the included articles aimed to study a test of HGS and/or the CST as screening tools for the detection of sarcopenia. However, four of the articles diagnosed possible or probable sarcopenia by using a test of HGS and/or the CST among elderly patients in a primary care setting. There is a need for more research to elucidate whether a test of HGS and/or the CST might be used for screening of sarcopenia in primary care.

Read More

Risk-stratified hepatocellular carcinoma screening according to the degree of obesity and progression to cirrhosis for diabetic patients with metabolic dysfunction-associated steatotic liver disease (MASLD) in Japan: a cost-effectiveness study

Objective
To evaluate the cost-effectiveness of risk-stratified hepatocellular carcinoma (HCC) screening in diabetic patients with metabolic dysfunction-associated steatotic liver disease (MASLD).

Design
A state-transition model from a healthcare payer perspective on a lifetime horizon.

Setting
Japan.

Population
A hypothetical cohort of 50-year-old diabetic patients with MASLD risk-stratified according to degree of obesity and progression to cirrhosis. Metabolic dysfunction-associated steatotic liver (MASL), metabolic dysfunction-associated steatohepatitis (MASH) and MASH cirrhosis are progressive manifestations of this specific type of liver disease.

Intervention
Abdominal ultrasound (US), US with alpha-fetoprotein (AFP), US with AFP and lectin-reactive alpha-fetoprotein (AFP-L3), CT, extracellular contrast-media-enhanced MRI (ECCM-MRI), gadoxetic acid-enhanced MRI (EOB-MRI) and no screening.

Main outcome measure
Costs, quality-adjusted life-years (QALYs), incremental cost-effectiveness ratios (ICERs), early-stage HCC cases, advanced-stage HCC cases and HCC-related deaths.

Results
EOB-MRI is the most cost-effective screening method for non-obese diabetic patients with MASH cirrhosis and for obese diabetic patients with MASH and MASH cirrhosis. Cost-effectiveness was sensitive to HCC incidence in non-obese diabetic patients with MASH cirrhosis and obese diabetic patients with MASH, and the adherence rate of HCC screening in obese diabetic patients with MASH. When the semiannual HCC incidence was between 0.008 and 0.0138 in non-obese diabetic patients with MASH cirrhosis, US with AFP was more cost-effective than EOB-MRI. Cost-effectiveness acceptability curves showed that EOB-MRI was 50.7%, 96.0% and 99.9% cost-effective in obese diabetic patients with MASH and non-obese diabetic patients with MASH cirrhosis, and obese diabetic patients with MASH cirrhosis at a willingness-to-pay level of $50 000 per QALY gained. Compared with no screening in 100 000 non-obese diabetic patients with MASH cirrhosis and obese diabetic patients with MASH cirrhosis, EOB-MRI reduced total costs by US$69 million and by US$142 million, increased lifetime effectiveness by 12 546 QALYs and by 15 815 QALYs, detected 17 873 and 21 014 early-stage HCC cases, and averted 2068 and 2471 HCC-related deaths, respectively.

Conclusions
Of all HCC screening methods for diabetic patients with MASH cirrhosis, EOB-MRI yields the greatest cost-saving with the highest QALYs, detects the greatest number of early-stage HCC cases and averts the greatest number of advanced-stage HCC cases and HCC-related deaths. The findings provide important insights for the precise implementation of risk-stratified HCC surveillance to reduce morbidity and mortality and improve the quality of life in diabetic patients with MASLD.

Read More

Cost-effectiveness of falls prevention strategies for older adults: protocol for a living systematic review

Introduction
One-third of adults aged 65+ fall annually. Injuries from falls can be devastating for individuals and account for 1.5% of annual healthcare spending. With the growing ageing population, falls place increased strain on scarce health resources. Prevention strategies that target individuals at high risk for falls demonstrate the best value for money; however, limited efficiency (ie, cost-effectiveness) information for fall prevention interventions hinders the implementation of effective falls prevention programmes. Living systematic reviews provide a timely up-to-date evidence-based resource to inform clinical guidelines and health policy decisions. This protocol details the methodology for a living systematic review of the efficiency (ie, cost-effectiveness) of fall prevention interventions for older adults in three settings: community-dwelling, aged care and hospitals.

Methods and analysis
This protocol used the reporting guidelines from the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocol. Peer-reviewed economic evaluations of controlled clinical trials or health state models will be included. Reports will be obtained through monthly systematic searches of CENTRAL (Ovid), CINAHL (EBSCO), Embase (Ovid), MEDLINE (Ovid), SCOPUS (Elsevier) and Web of Science (Clarivate) alongside snowballing and handsearching EconLit and the Tufts Cost Effectivness Analysis Registry. Screening, data extraction, quality assessment and risk of bias will be assessed by multiple reviewers. The primary outcomes will be the incremental cost-effectiveness (ie, incremental cost per fall prevented), incremental cost-utility (ie, incremental cost per quality-adjusted life year gained) or cost-benefit ratio. Additional outcomes will include falls and cost-related measures. All economic outcomes will be reported in a common year and currency. Results will be reported as a narrative synthesis; meta-analysis will be considered based on data quality, suitability and availability.

Ethics and dissemination
Ethical approval is not required as primary human data will not be collected. Results will be disseminated through peer-reviewed publications and a dedicated website.

PROSPERO registration number
CRD42024532485.

Read More

Delivering an innovative multi-infection and female genital mutilation screening to high-risk migrant populations (ISMiHealth): study protocol of a cluster randomised controlled trial with embedded process evaluation

Introduction
ISMiHealth is a clinical decision support system, integrated as a software tool in the electronic health record system of primary care, that aims to improve the screening performance on infectious diseases and female genital mutilation (FGM) in migrants. The aim of this study is to assess the health impact of the tool and to perform a process evaluation of its feasibility and acceptability when implemented in primary care in Catalonia (Spain).

Methods and analysis
This study is a cluster randomised control trial where 35 primary care centres in Catalonia, Spain will be allocated into one of the two groups: intervention and control. The health professionals in the intervention centres will receive prompts, through the ISMiHealth software, with screening recommendations for infectious diseases and FGM targeting the migrant population based on an individualised risk assessment. Health professionals of the control centres will follow the current routine practice.
A difference in differences analysis of the diagnostic rates for all aggregated infections and each individual condition between the intervention and control centres will be performed. Mixed-effects logistic regression models will be carried out to identify associations between the screening coverage and predictor factors. In addition, a process evaluation will be carried out using mixed methodology.

Ethics and dissemination
The study protocol has been approved by the institutional review boards at Hospital Clínic (16 June 2022, HCB/2022/0363), Clinical Research Ethics Committee of the Primary Care Research Institute IDIAPJGol (22 June 2022, 22/113-P) and the Almería Research Ethics Committee (27 July 2022, EMC/apg). The study will follow the tenets of the Declaration of Helsinki and Good Clinical Practice. All researchers and associates signed a collaboration agreement in which they undertake to abide by good clinical practice standards.
Findings will be disseminated in peer-reviewed journals and communications to congresses.

Trial registration number
NCT05868005.

Read More

Detection, linkage to care, treatment and monitoring of hypertension in coastal communities in Accra, Ghana: protocol for a quasi-experimental study (The Ghana Heart Initiative Hypertension Study)

Introduction
Over the past few decades, the prevalence of hypertension in Ghana has increased significantly. Insufficient diagnosis and suboptimal management of diagnosed cases result in increased mortality and morbidity due to poor blood pressure control and attendant complications. This highlights the need for new models of hypertension control in highly burdened, urban poor communities. This study aims to identify patients with hypertension in the coastal communities of the Greater Accra region, link patients newly diagnosed with hypertension to appropriate medical care and monitor treatment outcomes using task-shifting strategies.

Methods and analysis
In this quasi-experimental study, participants with a mean blood pressure of ≥140/90 mm Hg will be recruited from seven coastal communities of Ghana’s Greater Accra region. Based on proportion to the size of these communities, we will screen and recruit 10 000 and 3000 participants, respectively, from all study sites. We will link the recruited individuals to designated health facilities and follow them for a year to assess treatment outcomes, blood pressure control, adherence to treatment, anthropometric measurements, funduscopic assessment, urinalysis, blood urea nitrogen and creatinine level, ECG and echocardiograms. In addition, we will use mobile health technology to support community screening, blood pressure checks and remote monitoring of patients diagnosed with hypertension, as well as send messages on medication adherence and lifestyle changes. Furthermore, we will conduct focus group discussions among community members and indepth interviews with persons considered to be newly diagnosed with hypertension, community health workers and religious leaders/representatives to assess the knowledge and perceptions of different study participants regarding hypertension diagnosis, management, control, experiences and treatment.

Ethics and dissemination
The study was approved by the Ghana Health Service Ethics Review Committee (protocol identification number GHS-ERC 028/08/22). We will obtain written informed consent from each participant. In addition to journal publication, dissemination activities will include a report to the Ghana Health Service on the outcome of the project.

Trial registration number
ISRCTN76503336.

Read More

Validation of the adult asthma epidemiological score: a secondary analysis of the EPI-ASTHMA population-based study

Objective
The A2 score is an eight-question patient-reported outcome measure that has been validated for ruling in (score ≥4) and ruling out (score 0–1) asthma. However, this screening tool has been validated in a cohort similar to the derivation cohort used. This study aims to validate the predictive accuracy of the A2 score in a primary care population against general practitioner (GP) clinical assessment and to determine whether the proposed cut-offs are the most appropriate.

Design
This accuracy study is a secondary analysis of the EPI-ASTHMA population-based study.

Setting
Primary care centres in Portugal.

Participants
Random adult participants answered the A2 score by phone interview.

Outcomes
Those with an A2 score ≥1 (plus 5% with an A2 score of 0) were invited to a diagnostic visit carried out by a GP to confirm or not a diagnosis of asthma. Diagnostic accuracy was assessed using receiver operating characteristic (ROC) curves.

Results
A total of 1283 participants (median 54 (p25–p75 43–66) years; 60% women) were analysed. The A2 score showed high discriminatory power in identifying asthma, with an area under the ROC curve of 82.9% (95% CI 80.4% to 85.4%). The proposed cut-off ≥4 was the most appropriate to rule in asthma (specificity 83.1%, positive predictive value 62.4%, accuracy 78%). Similarly, the proposed cut-off

Read More

Microwave imaging for breast cancer screening: protocol for an open, multicentric, interventional, prospective, non-randomised clinical investigation to evaluate cancer detection capabilities of MammoWave system on an asymptomatic population across multiple European countries

Introduction
Microwave imaging presents several potential advantages including its non-ionising and harmless nature. This open, multicentric, interventional, prospective, non-randomised trial aims to validate MammoWave’s artificial intelligence (AI)-based classification algorithm, leveraging microwave imaging, to achieve a sensitivity exceeding 75% and a specificity exceeding 90% in breast screening.

Methods and analysis
10 000 volunteers undergoing regular mammographic breast cancer screening will be recruited across 9 European centres and invited to participate in the clinical study, involving MammoWave testing on both breasts. MammoWave results will be checked against the reference standard, to be intended as the output of conventional breast examination path (with histological confirmation of cancer cases) with 2 years follow-up. Anonymised clinical and MammoWave’s results, including microwave images, associated features and a label provided by the AI-based classification algorithm, will be collected and stored in a dedicated electronic case report form. The prospective study will involve a comparative analysis between the output of the conventional breast examination path (control intervention) and the labels provided by MammoWave’s AI system (experimental intervention). These labels will categorise breasts into two groups: breast With Suspicious Finding, indicating the presence of a suspicious lesion or No Suspicious Finding, indicating the absence of a lesion or the presence of a low-suspicion lesion. This trial aims to provide evidence regarding the novel MammoWave’s AI system for detecting breast cancer in asymptomatic populations during screening.

Ethics and dissemination
This study was approved by the Research Ethics Committee of the Liguria Region (CET), Italy (CET-Liguria: 524/2023—DB id 13399), the Research Ethics Committee of Complejo Hospitalario de Toledo (CEIC), Spain (CEIC-1094), the National Ethics Committee for Clinical Research (CEIC), Portugal (CEIC-2311KC814), the Bioethical Committee of Pomeranian Medical University in Szczecin, Poland (KB-006/23/2024) and the Zurich Cantonal Ethics Commission, Switzerland (BASEC 2023-D0101). The findings of this study will be disseminated through academic and scientific conferences as well as peer-reviewed journals.

Trial registration number
NCT06291896.

Read More